V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System (K223387)
Description
V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System by Samsung Medison Co., Ltd., an FDA 510(k) cleared radiology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223387
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System (K223387) cites 4 predicate devices and is itself cited by 4 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K220975 | V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound S... | Samsung Medison Co., Ltd. | 2022 |
| K221117 | RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultr... | Samsung Medison Co., Ltd. | 2022 |
| K220043 | HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic U... | Samsung Medison Co., Ltd. | 2022 |
| K210068 | HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasou... | Samsung Medison Co., Ltd. | 2021 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K242594 | DEEPECHO | Deepecho | 2025 |
| K243684 | BrightHeart View Classifier | Brightheart | 2025 |
| K233112 | HM70 EVO Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2023 |
| K231772 | V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultras... | Samsung Medison Co., Ltd. | 2023 |
Trace the full predicate network for K223387
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.